UK Devicemaker Warned by FDA on Documentation, Production

May 28, 2012
Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant. The May 2 letter cites Amplivox with a total of 10 violations, mostly tied to flawed procedures or documentation. Amplivox makes audiometers, spirometers, vision screeners and other occupational health products. For example, Amplivox did not have adequate procedures in place to identify, document and validate design changes before they were implemented. Nor did its device design methods include proper design validation, complete with risk analysis.
Devices & Diagnostics Letter